<?php
?>

<html><head>
<title>Application For Ethics Review(Part II)</title>
</head>
<body>
<hr></hr>
<h1 align="center"><b>Faculty of Medicine, University of Colombo</b></h1>
<h1 align="center"><b>Ethics Review Application  (Part II) - Protocol Checklist</b></h1>
<hr></hr>
<h5 align="left"><i>for official use</i></h6>
<form action="">
<label><font size="5">Application No:</font size></label><input name="AppNo" size="20" font size="8" maxlength=10 type="text" value=""></input>
<hr></hr>
<table border="0" width="1000" align="left">
<tr>
  <td><font size="5"><b>1.</b></td><td><label><font size="5"><b>Title of Protocol</b></label></td>
 </tr>
<tr>
  <td></td><td><input name="Title_Protocol" size="198" type="text" value=""></input></td>
 </tr>
<tr>
  <td><font size="5"><b>2.</b></td><td><label><font size="5"><b>Name of Principal Investigator</b></label></td>
 </tr>
<tr>
  <td></td><td><input name="Name_PrinsInvest" size="198" type="text" value=""></input></td>
 </tr>
<tr>
  <td><font size="5"><b>3.</b></td><td><font size="5"><b>A List of Documents Submitted for Review</b></td>
 </tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td><lable><font size="5"><b>Title of Document</b></lable></td><td><lable><font size="5"><b>Version</b></lable></td><td><lable><font size="5"><b>Date</b></lable></td><td><lable><font size="5"><b>Upload</b></lable></td><td><lable><font size="5"><b>Remove</b></lable></td>	
   </tr>
   <tr>
     <td><input name="TilteDoc1" size="120" type="text" value=""></input></td><td><input name="verDoc1" size="18" maxlength=10 type="text" value=""></input></td><td><input name="dateDoc1" size="20" maxlength=12 type="text" value=""></input></td>
   </tr>
   <tr>
     <td><input name="TilteDoc2" size="120" type="text" value=""></input></td><td><input name="verDoc2" size="18" maxlength=10 type="text" value=""></input></td><td><input name="dateDoc2" size="20" maxlength=12 type="text" value=""></input></td>
   </tr>
   <tr>
     <td><input name="TilteDoc3" size="120" type="text" value=""></input></td><td><input name="verDoc3" size="18" maxlength=10 type="text" value=""></input></td><td><input name="dateDoc3" size="20" maxlength=12 type="text" value=""></input></td>
   </tr>
   <tr>
     <td><input name="TilteDoc4" size="120" type="text" value=""></input></td><td><input name="verDoc4" size="18" maxlength=10 type="text" value=""></input></td><td><input name="dateDoc4" size="20" maxlength=12 type="text" value=""></input></td>
   </tr>
   <tr>
     <td><input name="TilteDoc5" size="120" type="text" value=""></input></td><td><input name="verDoc5" size="18" maxlength=10 type="text" value=""></input></td><td><input name="dateDoc5" size="20" maxlength=12 type="text" value=""></input></td>
   </tr>
   <tr>
     <td><input name="TilteDoc6" size="120" type="text" value=""></input></td><td><input name="verDoc6" size="18" maxlength=10 type="text" value=""></input></td><td><input name="dateDoc6" size="20" maxlength=12 type="text" value=""></input></td>
   </tr>
   <tr>
     <td><input name="TilteDoc7" size="120" type="text" value=""></input></td><td><input name="verDoc7" size="18" maxlength=10 type="text" value=""></input></td><td><input name="dateDoc7" size="20" maxlength=12 type="text" value=""></input></td>
   </tr>
   </table></td>
 </tr>
<tr>
  <td><font size="5"><b>4.</b></td><td><font size="5"><b>Protocol Checklist</b></td>
 </tr>
<tr>
  <td></td><td><font size="5">Please indicate the Following:</td>
 </tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Collaaborative partnership</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The collaborations you have established with institutions where the study is to be conducted</td><td><input name="applicYesCo_1" type="checkbox" value="yes"</input></td><td><input name="applicNOCo_1" type="checkbox" value="no"</input></td><td><input name="protSecNoCo_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCo_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>The collaborations you have established with the community where the study is to be conducted</td><td><input name="applicYesCo_2" type="checkbox" value="yes"</input></td><td><input name="applicNOCo_2" type="checkbox" value="no"</input></td><td><input name="protSecNoCo_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCo_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>The benifits to institutions, communities, and participants in your research</td><td><input name="applicYesCo_3" type="checkbox" value="yes"</input></td><td><input name="applicNOCo_3" type="checkbox" value="no"</input></td><td><input name="protSecNoCo_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCo_3" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Social Value</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The benificiaries of your research and benifit to them</td><td><input name="applicYesSo_1" type="checkbox" value="yes"</input></td><td><input name="applicNOSo_1" type="checkbox" value="no"</input></td><td><input name="protSecNoSo_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesSo_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>The plan for dissemination of study findings</td><td><input name="applicYesSo_2" type="checkbox" value="yes"</input></td><td><input name="applicNOSo_2" type="checkbox" value="no"</input></td><td><input name="protSecNoSo_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesSo_2" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Scientific Validity</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The Scientific importance of your study in relation to improving health care and/ or knowledge on the subject. </td><td><input name="applicYesSc_1" type="checkbox" value="yes"</input></td><td><input name="applicNOSc_1" type="checkbox" value="no"</input></td><td><input name="protSecNoSc_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesSc_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>The justification for a replication study, if your study is a replication study.</td><td><input name="applicYesSc_2" type="checkbox" value="yes"</input></td><td><input name="applicNOSc_2" type="checkbox" value="no"</input></td><td><input name="protSecNoSc_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesSc_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>How the sample size was calculated</td><td><input name="applicYesSc_3" type="checkbox" value="yes"</input></td><td><input name="applicNOSc_3" type="checkbox" value="no"</input></td><td><input name="protSecNoSc_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesSc_3" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Assesment of Risks/Benifits</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The risks to research subjects</td><td><input name="applicYesRi_1" type="checkbox" value="yes"</input></td><td><input name="applicNORi_1" type="checkbox" value="no"</input></td><td><input name="protSecNoRi_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRi_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>Benifits to research subjects</td><td><input name="applicYesRi_2" type="checkbox" value="yes"</input></td><td><input name="applicNORi_2" type="checkbox" value="no"</input></td><td><input name="protSecNoRi_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRi_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>Steps taken to minimize risks</td><td><input name="applicYesRi_3" type="checkbox" value="yes"</input></td><td><input name="applicNORi_3" type="checkbox" value="no"</input></td><td><input name="protSecNoRi_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRi_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>Steps taken to enhance benifits</td><td><input name="applicYesRi_4" type="checkbox" value="yes"</input></td><td><input name="applicNORi_4" type="checkbox" value="no"</input></td><td><input name="protSecNoRi_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRi_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>Justification of the potential benifits against the risks</td><td><input name="applicYesRi_5" type="checkbox" value="yes"</input></td><td><input name="applicNORi_5" type="checkbox" value="no"</input></td><td><input name="protSecNoRi_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRi_5" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>6.</td><td>Support provided to the research participants (medical, psychological and other)</td><td><input name="applicYesRi_6" type="checkbox" value="yes"</input></td><td><input name="applicNORi_6" type="checkbox" value="no"</input></td><td><input name="protSecNoRi_6" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRi_6" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Consent</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The procedure for initial contact of participants</td><td><input name="applicYesCon_1" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_1" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>The procedure for obtaining informed consent</td><td><input name="applicYesCon_2" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_2" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>The information (written/ oral) provided to participants</td><td><input name="applicYesCon_3" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_3" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>The procedure for ensuring that subjects have understood the information provided</td><td><input name="applicYesCon_4" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_4" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>The procedure for obtaining proxy consent</td><td><input name="applicYesCon_5" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_5" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_5" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>6.</td><td>The procedure for withdrawing consent</td><td><input name="applicYesCon_6" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_6" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_6" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_6" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>7.</td><td>Incentives/ rewards/ compansation provided to participants</td><td><input name="applicYesCon_7" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_7" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_7" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_7" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>8.</td><td>The procedure for re-consenting if the research protocol changes during the course of research</td><td><input name="applicYesCon_8" type="checkbox" value="yes"</input></td><td><input name="applicNOCon_8" type="checkbox" value="no"</input></td><td><input name="protSecNoCon_8" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCon_8" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Confidentiality</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>How the data and samples will be obtained</td><td><input name="applicYesCnf_1" type="checkbox" value="yes"</input></td><td><input name="applicNOCnf_1" type="checkbox" value="no"</input></td><td><input name="protSecNoCnf_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCnf_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>How long the data and samples will be kept</td><td><input name="applicYesCnf_2" type="checkbox" value="yes"</input></td><td><input name="applicNOCnf_2" type="checkbox" value="no"</input></td><td><input name="protSecNoCnf_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCnf_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>Justification for collection of personal identification data</td><td><input name="applicYesCnf_3" type="checkbox" value="yes"</input></td><td><input name="applicNOCnf_3" type="checkbox" value="no"</input></td><td><input name="protSecNoCnf_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCnf_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>Who will have access to the personal data of the reseaech participants</td><td><input name="applicYesCnf_4" type="checkbox" value="yes"</input></td><td><input name="applicNOCnf_4" type="checkbox" value="no"</input></td><td><input name="protSecNoCnf_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCnf_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>How the confidentiality of participants will be ensured</td><td><input name="applicYesCnf_5" type="checkbox" value="yes"</input></td><td><input name="applicNOCnf_5" type="checkbox" value="no"</input></td><td><input name="protSecNoCnf_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCnf_5" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>6.</td><td>The procedure for data and sample storage</td><td><input name="applicYesCnf_6" type="checkbox" value="yes"</input></td><td><input name="applicNOCnf_6" type="checkbox" value="no"</input></td><td><input name="protSecNoCnf_6" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCnf_6" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>7.</td><td>The procedure for data and sample disposal</td><td><input name="applicYesCnf_7" type="checkbox" value="yes"</input></td><td><input name="applicNOCnf_7" type="checkbox" value="no"</input></td><td><input name="protSecNoCnf_7" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCnf_7" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Rights of the participants</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr> 
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>Procedure for subjects to withdraw from the research at any time</td><td><input name="applicYesR_1" type="checkbox" value="yes"</input></td><td><input name="applicNOR_1" type="checkbox" value="no"</input></td><td><input name="protSecNoR_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesR_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>Proceedure for subjects to ask questions and register complains</td><td><input name="applicYesR_2" type="checkbox" value="yes"</input></td><td><input name="applicNOR_2" type="checkbox" value="no"</input></td><td><input name="protSecNoR_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesR_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>The contact person for research subjects</td><td><input name="applicYesR_3" type="checkbox" value="yes"</input></td><td><input name="applicNOR_3" type="checkbox" value="no"</input></td><td><input name="protSecNoR_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesR_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>Provisions for participants to be informed of results</td><td><input name="applicYesR_4" type="checkbox" value="yes"</input></td><td><input name="applicNOR_4" type="checkbox" value="no"</input></td><td><input name="protSecNoR_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesR_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>Provision to make the study product available to the study participants after the research</td><td><input name="applicYesR_5" type="checkbox" value="yes"</input></td><td><input name="applicNOR_5" type="checkbox" value="no"</input></td><td><input name="protSecNoR_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesR_5" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Fair participant selection</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr> 
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The justification the selection of the study population</td><td><input name="applicYesJ_1" type="checkbox" value="yes"</input></td><td><input name="applicNOJ_1" type="checkbox" value="no"</input></td><td><input name="protSecNoJ_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesJ_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>The inclusion and exclusion criteria</td><td><input name="applicYesJ_2" type="checkbox" value="yes"</input></td><td><input name="applicNOJ_2" type="checkbox" value="no"</input></td><td><input name="protSecNoJ_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesJ_2" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Responsibilities of the researcher</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr> 
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The provision of medical services to research participants</td><td><input name="applicYesRes_1" type="checkbox" value="yes"</input></td><td><input name="applicNORes_1" type="checkbox" value="no"</input></td><td><input name="protSecNoRes_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRes_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>The provision of continuation of care after the reseaarch is completed</td><td><input name="applicYesRes_2" type="checkbox" value="yes"</input></td><td><input name="applicNORes_2" type="checkbox" value="no"</input></td><td><input name="protSecNoRes_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRes_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>Declaration of conflicts of interest and how the investigators plan to manage the conflicts</td><td><input name="applicYesRes_3" type="checkbox" value="yes"</input></td><td><input name="applicNORes_3" type="checkbox" value="no"</input></td><td><input name="protSecNoRes_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRes_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>The ethical/ legal/ social and financial issues relevent to the study</td><td><input name="applicYesRes_4" type="checkbox" value="yes"</input></td><td><input name="applicNORes_4" type="checkbox" value="no"</input></td><td><input name="protSecNoRes_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesRes_4" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Vulnerable populations</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr> 
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>Justification for conducting the study in this population</td><td><input name="applicYesV_1" type="checkbox" value="yes"</input></td><td><input name="applicNOV_1" type="checkbox" value="no"</input></td><td><input name="protSecNoV_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesV_1" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Research funded by foreign agencies/ companies</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>Justification for conducting the study in Sri Lanka</td><td><input name="applicYesFo_1" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_1" type="checkbox" value="no"</input></td><td><input name="protSecNoFo_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesFo_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>Relevance of the study to Sri Lanka</td><td><input name="applicYesFo_2" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_2" type="checkbox" value="no"</input></td><td><input name="protSecNoFo_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesFo_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>Post research benifits to Sri Lanka</td><td><input name="applicYesFo_3" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_3" type="checkbox" value="no"</input></td><td><input name="protSecNoFo_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesFo_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>The steps taken to take into account cultural and social customs,practices, and taboos in Sri Lanka</td><td><input name="applicYesFo_4" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_4" type="checkbox" value="no"</input></td><td><input name="protSecNoFo_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesFo_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>The sharing of rights of interlectual property</td><td><input name="applicYesFo_5" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_5" type="checkbox" value="no"</input></td><td><input name="protSecNoFo_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesFo_5" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>6.</td><td>The fate of data and biological samples including whether they will be transferred abroad and what will happen to them after the conclusion of the study</td><td><input name="applicYesFo_6" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_6" type="checkbox" value="no"</input></td><td><input name="protSecNoFo_6" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesFo_6" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>7.</td><td>How the results of research will be conveyed to relevent authorities in Sri Lanka</td><td><input name="applicYesFo_7" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_7" type="checkbox" value="no"</input></td><td><input name="protSecNoFo_7" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesFo_7" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>8.</td><td>The agreement between the sponsor/ funding agency and the investigator</td><td><input name="applicYesFo_8" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_8" type="checkbox" value="no"</input></td><td>Please Attach</td><td><input name="reviwerChYesFo_8" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>9.</td><td>The materials transfer agreement, if biological material is to be transferred abroad</td><td><input name="applicYesFo_9" type="checkbox" value="yes"</input></td><td><input name="applicNOFo_9" type="checkbox" value="no"</input></td><td>Please Attach</td><td><input name="reviwerChYesFo_9" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Community based research</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr> 
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>The impact and relevance of the research on the community in which it is to be carried out</td><td><input name="applicYesCm_1" type="checkbox" value="yes"</input></td><td><input name="applicNOCm_1" type="checkbox" value="no"</input></td><td><input name="protSecNoCm_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCm_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>		
     <td>2.</td><td>The steps taken to consult with the concerned community during the design of the research</td><td><input name="applicYesCm_2" type="checkbox" value="yes"</input></td><td><input name="applicNOCm_2" type="checkbox" value="no"</input></td><td><input name="protSecNoCm_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCm_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>The procedure used to obtain community consent</td><td><input name="applicYesCm_3" type="checkbox" value="yes"</input></td><td><input name="applicNOCm_3" type="checkbox" value="no"</input></td><td><input name="protSecNoCm_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCm_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>The contribution to capacity building of the community</td><td><input name="applicYesCm_4" type="checkbox" value="yes"</input></td><td><input name="applicNOCm_4" type="checkbox" value="no"</input></td><td><input name="protSecNoCm_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCm_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>The procedure for making available results of research to the community</td><td><input name="applicYesCm_5" type="checkbox" value="yes"</input></td><td><input name="applicNOCm_5" type="checkbox" value="no"</input></td><td><input name="protSecNoCm_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCm_5" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td rowspan="2" colspan="2"><font size="5"><b>Clinical trials</b></td><td colspan="2"><font size="5"><b>Applicable</b></td><td rowspan="2"><font size="5"><b>Protocol Section Number</b></td><td rowspan="2"><font size="5"><b>Reviewer checked</b></td> 
   </tr>
   <tr>
     <td><font size="5"><b>Yes</b></td><td><font size="5"><b>No</b></td>
   </tr>
   <tr>
     <td>1.</td><td>Justification for withdrawing any therapy from participants to prepare them for the trial</td><td><input name="applicYesCl_1" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_1" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>     
     <td>2.</td><td>Justification for withholding standard therapy from trial participants (eg. control group)</td><td><input name="applicYesCl_2" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_2" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>Justification for providing care which is not the standard of care</td><td><input name="applicYesCl_3" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_3" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>procedure for dealing with adverse events</td><td><input name="applicYesCl_4" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_4" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>procedure for reporting adverse events</td><td><input name="applicYesCl_5" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_5" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_5" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>6.</td><td>provisions for safety monitoring</td><td><input name="applicYesCl_6" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_6" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_6" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_6" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>7.</td><td>Provisions/ criteria for termination of the trial</td><td><input name="applicYesCl_7" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_7" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_7" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_7" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>8.</td><td>Provisions for making the trial drug available to the participants after the trial if found to be effective</td><td><input name="applicYesCl_8" type="checkbox" value="yes"</input></td><td><input name="applicNOCl_8" type="checkbox" value="no"</input></td><td><input name="protSecNoCl_8" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChYesCl_8" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
<tr>
  <td></td><td><table border="1" width="1000" align="left">
   <tr>
     <td colspan="2"><font size="5"><b>Information Sheet (IFS)/ Informed Consent form (ICF) Check List</b></td><td><font size="5"><b>Section IFS/ ICF</b></td><td><font size="5"><b>Reviewer Checked</b></td> 
   </tr>
   <tr>
     <td colspan="2"><font size="4">List the sections in IFS/ ICS where you have delt with the following:</td><td></td><td></td> 
   </tr>
   <tr>
     <td>1.</td><td>Purpose of the study</td><td><input name="sectionIFS/ICS_1" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_1" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>2.</td><td>Voluntary participation</td><td><input name="sectionIFS/ICS_2" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_2" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>3.</td><td>Duration, procedures of the study and participant's reponsibilities</td><td><input name="sectionIFS/ICS_3" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_3" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>4.</td><td>Potential benifits</td><td><input name="sectionIFS/ICS_4" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_4" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>5.</td><td>Risks, hazards and discomforts</td><td><input name="sectionIFS/ICS_5" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_5" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>6.</td><td>Reimbersments</td><td><input name="sectionIFS/ICS_6" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_6" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>7.</td><td>Confidentiality</td><td><input name="sectionIFS/ICS_7" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_7" type="checkbox" value="yes"</input></td>  
   </tr>
   <tr>
     <td>8.</td><td>Termination of study participation</td><td><input name="sectionIFS/ICS_8" size="12" maxlength=12 type="text" value=""></input></td><td><input name="reviwerChIFS/ICS_8" type="checkbox" value="yes"</input></td>  
   </tr>
   </table></td>
</tr>
</form>

</body>
</html>